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A Prospective, Single-arm Study Evaluating the Endothelialization Effect and Timeline of AnchorMan® Left Atrial Appendage Occluder in Non-valvular Atrial Fibrillation Patients at High Risk of Stroke

NCT07396493 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2026-02-09

No results posted yet for this study

Summary

This study aims to evaluate the endotheliation efficacy of the AnchorMane® Left Atrial Appendage Occluder in non-valvular atrial fibrillation patients at high stroke risk. It investigates the rate of complete endotheliation of the occluder at 6 months post-procedure using routine cardiac CTA, providing additional data for clinical application and further product development.

Study Size and Duration: This study plans to enrol1 306 patients. All participants will undergo follow up immediately after occluder implantation, prior to discharge or within 7 days post-procedure, at 1 month post-procedure, at 3 months post-procedure,and at 6 months post-procedure. The total study duration is projected to be 3 year.

The expected duration of participation for each participant is approximately 6 months.

Conditions

  • Non-valvular Atrial Fibrillation (NVAF)
  • High Risk of Stroke

Interventions

PROCEDURE

Intra-operative application of LAAC

Undergoing left atrial appendage occlusion device for followup observation of the time course of device surface with the.endotheliation.

Sponsors & Collaborators

  • Ruijin Hospital

    collaborator OTHER

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Zhoupu Hospital, Pudong New Area, Shanghai, China

    collaborator OTHER

  • Changhai Hospital

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-08
Primary Completion
2027-06-12
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07396493 on ClinicalTrials.gov